Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator;
History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
Any screening laboratory, electrocardiogram (ECG), or other findings that, in the opinion of the investigator or the sponsor, indicate an unacceptable risk for the subject's participation in the study.
History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion
Cardiac ejection fraction >= 45%, no evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
Corrected QT Interval (QTc) > 470 milliseconds (msec) on a 12-lead ECG obtained during the screening period\r\n* Note: If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG
Major abnormalities identified by ECG or echocardiogram (ECHO), at the Investigator's discretion.
Any of the following ECG findings or assessments including: Baseline QTcF interval >=450 milliseconds; Clinically significant ECG assessments should be reviewed by the site cardiologist prior to study entry.
Subject has an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically significant and would preclude study participation.
Have electrocardiogram (ECG) with no clinically significant findings as assessed by the investigator performed within 28 days prior to first dose;
Significant cardiac disease as determined by the investigator including:\r\n* Known or suspected cardiac amyloidosis\r\n* Congestive heart failure of class III or IV of the New York Heart Association (NYHA) classification\r\n* Uncontrolled angina, hypertension or arrhythmia\r\n* Myocardial infarction in the past 6 months\r\n* Any uncontrolled or severe cardiovascular disease\r\n* Corrected QT Interval (QTc) > 470 milliseconds (msec) on a 12-lead electrocardiogram (ECG) obtained during the screening period. If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG
Cardiac function (12 lead- electrocardiogram [ECG] versus [vs] non-12 lead ECG), performed within 14 days prior to day 1 of protocol therapy
Presence of an abnormal ECG
History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
Subject has familial short QT syndrome, is receiving medications that are known to shorten the QT interval, or has a clinically significant abnormal electrocardiogram (ECG).
Cardiac ejection fraction >= 45%, no evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
Corrected QT (QTc) > 470 milliseconds (msec) on a 12-lead ECG obtained during the screening period; Note: If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG
Abnormalities on 12-lead electrocardiogram (ECG) considered by the investigator to be clinical significant.
To be performed within 10 business days prior to day 1: Cardiac function (12 lead-electrocardiogram [ECG] versus [vs] non 12 led ECG) shows no underlying arrhythmia or heart blocks (for VRP only)
Patient must have a 12-lead ECG with ALL of the following parameters at screening:
Screening 12-lead electrocardiogram (ECG) with a measurable QTc interval according to Fridericia’s correction > 450 ms
Patients with clinically relevant abnormal electrocardiography (ECG) findings, including abnormal corrected QT interval (QTc) > 500 ms on screening ECG (note: if a patient has a QTc interval > 500 ms on screening ECG, the screening ECG may be repeated twice [at least 24 hours apart] for a total of 3 ECGs)
Normal cardiac function as assessed by electrocardiogram (ECG) and echocardiogram
Corrected QT(c) >= 481 ms (>= grade 2) on electrocardiogram (ECG) prior to initiation of treatment\r\n* If baseline QTc on screening ECG meets exclusion criteria:\r\n** Check potassium and magnesium serum levels\r\n** Correct any identified hypokalemia and/or hypomagnesemia and repeat ECG to confirm exclusion of patient due to QTc\r\n* For patients with HR 60-100 bpm, no manual read of QTc is required\r\n* For patients with baseline HR < 60 or > 100 bpm, manual read of QT by cardiologist is required, with Fridericia correction applied to determine QTc
Corrected QT (QTc) > 480 ms (grade 2 or greater) on screening electrocardiogram (ECG)\r\n* If baseline QTc on screening ECG meets exclusion criteria on screening assessment:\r\n** Check potassium and magnesium levels\r\n** Correct any identified hypokalemia and/or hypomagnesemia and repeat ECG to confirm exclusion of patient due to QTc\r\n** For patients with a heart rate (HR) 60-100 bpm, no manual read of QT is required\r\n** For patients with baseline HR < 60 or > 100 bpm, manual read of QT by cardiologist is required using Fridericia correction
Corrected QT (QTc) > 470 milliseconds (msec) on a 12-lead ECG obtained during the Screening period\r\n* Note: If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG
History or presence of an abnormal ECG, ECHO, or MUGA that is clinically meaningful.
Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the PI
Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the PI
Clinically significant abnormal 12-lead ECG findings;
Screening ECG abnormality documented by the investigator as medically significant
History or presence of an ECG that, in the investigator's opinion, is clinically meaningful as per protocol-defined criteria.
Cardiac ejection fraction >= 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
Cardiac ejection fraction >= 40%, and no clinically significant electrocardiogram (ECG) findings.
History or presence of an abnormal electrocardiogram (ECG)
Major abnormalities identified by electrocardiogram (ECG) or echocardiogram (ECHO), at the investigator’s discretion
Inability to measure QT interval on ECG
Electrocardiogram (ECG) abnormalities indicative of arrhythmia (at the discretion of the investigator)
Patient must have an electrocardiogram (ECG) performed within 42 days prior to registration; patient must not have mean corrected QT (QTc) > 500 msec (with Bazett’s correction) in screening electrocardiogram, or other significant ECG abnormality, New York Heart Association (NYHA) classification III or IV; patient must not require concurrent use of drugs or biologics with proarrhythmic potential
History or presence of abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful
Patients must have a baseline electrocardiogram (ECG) performed within 42 days of registration that is normal or considered not clinically significant by the site investigator
History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful.
Any of the following ECG findings: Baseline QTcF interval >=450 millisecond (msec); Any clinically significant ECG assessments should be reviewed by the site cardiologist prior to study entry.
Have a 12-lead Electrocardiogram (ECG) that is not clinically significant at screening, as determined by the investigator
History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful.
history or family history of long QT syndrome; 12-Lead electrocardiogram (ECG) abnormalities considered by the investigator to be clinically significant or QTcF ? 450 milliseconds, regardless of clinical significance, at screening. Abnormal ECG may be confirmed with one repeat assessment. For subjects with QTcF ? 450 msec on initial ECG, the mean of the two QTcF assessments will determine eligibility;
Subjects must have normal or clinically insignificant ECG at screening
Known cardiomyopathy and/or clinical significant abnormal ECG findings at Screening disqualifying the patient from nephrectomy and from subsequent sunitinib treatment
Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note: participants with chronic atrial arrhythmia, ie, atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible). A clinically significant ECG abnormality, including a marked prolonged QT/QTc interval (eg, a repeated demonstration of a QTc interval of greater than 500 ms).
Active, clinically significant Electrocardiogram (ECG) abnormalities
Any of the following electrocardiogram (ECG) findings: Baseline QTcF >=450 millisecond (msec). NOTE: Any clinically significant ECG assessments should be reviewed by the site cardiologist prior to study entry.
Evidence of transmural infarction on ECG
Clinically significant abnormality on electrocardiogram (ECG)
Corrected QT interval using Bazett's formula (QTcB) > 470 milliseconds (msec) on a 12-lead electrocardiogram (ECG) obtained during the screening period; if a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG
Inability to determine the QT interval on ECG
Unstable coronary disease or clinically significant electrocardiogram (ECG) (12-lead) abnormalities, as determined by the investigator
Acute or relevant abnormalities in electrocardiogram (ECG)
The patient has LVEF ?40% by ECHO or MUGA scan and no clinically significant abnormalities in 12-lead ECG
Electrocardiogram (ECG): Patients with normal ECG, Asymptomatic patients with abnormal ECGs not requiring medical intervention
Inability to monitor the QT interval on electrocardiogram (ECG)
Evidence of transmural infarction on electrocardiogram (ECG)
Have documented major electrocardiogram (ECG) abnormalities at the investigator's discretion
Resting ECG with clinically significant abnormal findings;
Significant screening electrocardiogram (ECG) abnormalities;
Inability to measure QT interval on ECG
Clinically significant abnormalities, other than HCV infection, in a participant with HCC based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the participant an unsuitable candidate for this study in the opinion of the investigator.
Has acute myocardial infarction within 6 months before starting study drug, current or history of New York Heart Association Class III or IV heart failure; evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or electrocardiogram (ECG) evidence of acute ischemia or active conduction system abnormalities; Fridericia's corrected QT interval > 475 milliseconds (msec) (males) or > 450 msec (females) on a 12-lead ECG during the Screening period; or abnormalities on 12-lead ECG including, but not limited to, changes in rhythm and intervals that in the opinion of the investigator are considered to be clinically significant.
Clinically significant ECG changes
Normal 12-lead ECG (clinically insignificant abnormalities permitted)
History of myocardial infarction or stroke within the last 6 months, or history of uncontrolled cardiovascular or cerebrovascular disease; a 12-lead electrocardiogram (ECG) will be performed during the screening period
Have either a normal ECG or one with abnormalities that are considered clinically insignificant by the investigator in consultation with the Sponsor
Abnormal 12-lead electrocardiogram (ECG) judged to be clinically significant by the Investigator;
Electrocardiogram (ECG) within normal limits
Electrocardiogram (ECG) obtained at Screening which shows QTc prolongation or other medically relevant abnormalities which may affect subject safety or interpretation of study results
Inability to measure QT interval on ECG
Normal electro cardio gram (ECG) or ECG with no clinically significant findings;
Subject with electrocardiogram (ECG) abnormalities on a 12-lead ECG performed within 14 days before start of the study drug that are considered by the Investigator to be clinically significant.
All patients must have an electrocardiogram (ECG) within 2 weeks of starting conditioning
ECG with no clinically significant findings;
Important abnormalities of the ECG that may interfere with the interpretation of QTc interval changes at screening
Electrocardiogram (12-lead ECG) QTc ? 480 ms
Serious cardiac condition such as myocardial infarction within the past 6 months, unstable angina, or Class III or IV congestive heart failure as defined by the New York Heart Association (NYHA); have ECG abnormalities including baseline 12-lead ECG with Fridericia-corrected QT interval (QTcF) > 470 msec (female) or > 450 msec (male), a history of congenital long QT syndrome, or any ECG abnormality that, in the opinion of the Investigator, would preclude safe participation in the study
History of severe cardiac disease or clinically significant arrhythmia (either on ECG or by history) which, in the opinion of the Investigator, will interfere with the safety of the individual subject.
All patients must have an electrocardiogram (ECG) within 2 weeks of starting conditioning
Abnormalities on 12-lead ECG including, but not limited to, changes in rhythm and intervals that, in the opinion of the investigator, are considered to be clinically significant.
Patients with a clinically significant abnormality on screening electrocardiogram (ECG) (taken within 12 weeks) that in the opinion of the investigator/co-investigator may increase the patient’s cardiovascular risk in this study
abnormal electrocardiogram or V02 test results,
Clinically significant abnormalities on electrocardiogram (ECG) at screening.
History or presence of an abnormal ECG that in the investigator's opinion is clinically meaningful.
12-lead ECG with QTc interval within defined limit
Clinically severe cardiovascular disease or clinically significant electrocardiogram (ECG) abnormality.
The patient has had a myocardial infarction in the previous 12 weeks. (Prior to study entry, electrocardiogram [ECG] abnormalities at screening must be documented by the investigator as not medically relevant.)
Clinically significant abnormalities on electrocardiogram (ECG)
Abnormalities on 12-lead ECG including, but not limited to, changes in rhythm and intervals that in the opinion of the investigator are considered to be clinically significant.